MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMPL SYS W/ PEEK SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMPL SYS W/ PEEK SWVLK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by an infectious disease facility representative via phone that a patient who underwent surgery on 3/1/2023 is now experiencing an infection.An ar-1665psl peek loop 'n' tack¿ tenodesis implant system and an ar-2600sbs-6 speedbridge implant system with peek swivelock anchors were implanted during the surgery.No further information was reported.Additional information requested.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is patient specific event, specifically, an allergic-like reactions to de implanted devices.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.
Event or Problem Description
Additional information received on 11/13/2023: the infectious disease facility representative does not know where the procedure took place or the information of the surgeon.The procedure was performed on the right shoulder, and the arthrex products are still implanted.The infection was identified on (b)(6) 2023 but it's unknown if it's deep or superficial.The infection was treated with a right shoulder arthroscopic and open i&d.Additional information was requested.

• Brand Name: SPEEDBRG IMPL SYS W/ PEEK SWVLK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18190193
• Report Number: 1220246-2023-08859
• Device Sequence Number: 7275319
• Product Code: MAI
• UDI-Device Identifier: 00888867160224
• UDI-Public: 00888867160224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SPEEDBRG IMPL SYS W/ PEEK SWVLK
• Device Catalogue Number: AR-2600SBS-6
• Device Lot Number: 15055254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown